ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
FDA 510(k) clearance K213781 · decided 2022-01-18
Clearance details
- K-number
- K213781
- Device name
- ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
- Applicant
- Depuy Ireland UC
- Decision
- Substantially Equivalent
- Date received
- 2021-12-03
- Decision date
- 2022-01-18
- Days to decision
- 46 days
- Clearance type
- Special
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ringaskiddy, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of th recall (Z-1456-2024) | DePuy Orthopaedics, Inc. | 2024-03-29 |